The present invention pertains to deep computing applications in medical device systems, and particularly employing deep computing techniques to derive statistical data bases and patient specific data files contributed from multiple data repositories, including implantable medical devices (IMDs), external medical devices and other sources, to formulate patient specific medical history monitoring, diagnostic, therapeutic and educational information and to deliver the information to the patient and/or patient health care provider.
A wide variety of IMDs have been developed for use in the human body to monitor a patient""s condition and/or to treat a patient""s underlying disease states. Such IMDs include implantable cardiac pacemakers, implantable cardioverter/defibrillators (ICDs), pacemaker/cardioverter/defibrillators, cardiomyostimulators, drug delivery systems, cardiac and other physiologic monitors, electrical stimulators including nerve, muscle, and deep brain stimulators, cochlear implants, and heart assist IMDs or pumps, etc.
At present, a wide variety of IMDs are commercially released or proposed for clinical implantation that are programmable in a variety of operating modes and are interrogatable using RF telemetry transmissions in telemetry sessions initiated between the IMD and an externally-located medical device (EMD). The terms xe2x80x9ctelemeterxe2x80x9d, xe2x80x9ctelemetry transmissionxe2x80x9d and the like are intended to embrace any action and manner of communicating and conveying patient or physiologic data and downlink telemetry data between the IMD and any type of EMD in the bi-directional uplink and downlink telemetry transmissions.
Typically, certain therapy delivery and monitoring operational modes and parameters of the IMD are altered temporarily or chronically in a non-invasive (i.e. non-surgical) manner using downlink telemetry transmission from an EMD of programming and interrogation commands or downlink messages herein also referred to as xe2x80x9cdownlink telemetry dataxe2x80x9d. Moreover, a wide variety of real time and stored physiologic data as well as non-physiologic, IMD related, data or previously stored implant data (referred to collectively herein as xe2x80x9cIMD developed patient dataxe2x80x9d) composed into uplink messages and are uplink telemetered by the IMD to the EMD in response to a downlink telemetered interrogation command that is received by the IMD transceiver.
The EMD is typically characterized as a full function or limited function xe2x80x9cprogrammerxe2x80x9d. The full function programmers are implemented with a full range of programming and interrogation capabilities and are intended for use by a physician or other health care provider to communicate with the IMD. In certain instances, patients are provided with limited function programmers (really wouldn""t refer to a remote monitor/transponder as a xe2x80x9cprogrammerxe2x80x9d) that typically have a limited range of programming functions (or no programming functions at allxe2x80x94like an RF head connected to a modem) and are intended for use by the patient to downlink telemeter a command to the IMD to deliver a therapy or change a therapy and/or to store physiologic data when the patient experiences particular symptoms or send a command instructing the IMD to xe2x80x9cuploadxe2x80x9d stored data.
Such a two-way telemetry session is typically initiated in the presence of a health care provider that is a treating or implanting physician or a physician""s assistant or the like, who is technically and medically trained sufficiently to operate the programmer, safely reprogram an operating mode or parameter of the IMD, and initiate uplink telemetry of patient data. Normally, this is done in a clinic, hospital room or physician""s office at implant and periodically as deemed advisable during the time that the IMD remains implanted. The patient may have to travel a distance and take time away from employment to participate in the telemetry session. The patient would have to stay under medical care indefinitely if the medical conditions of the patient warrant continuous monitoring of the IMD.
Multiple generations of IMDs of each type may be implanted in the worldwide patient population at any given time because new IMD types and IMD generations are constantly being introduced while longevity of previously implanted IMDs continues to increase. Typically, each new generation of IMD offers more operating modes, parameters, and patient data storage capacity than its predecessor. Consequently, the types and volume of patient data that can be accumulated or sampled in use also increases, placing additional requirements on the telemetry and programming functions that are to be managed by health care providers using the supplied programmer. Thus, health care providers find it necessary to frequently upgrade their training in evaluating new patient candidates, diagnosing their medical condition, prescribing the proper IMD, and then in programming its operating modes and parameters and monitoring features in order to provide the optimum therapy and obtain useful patient data over time.
Moreover, the types of patient data that are developed by various sensors and operating systems of IMDs continue to expand. One such implantable EGM monitor for recording the cardiac electrogram from electrodes remote from the heart as disclosed in commonly assigned U.S. Pat. No. 5,331,966 and PCT publication WO 98/02209 is embodied in the Medtronic(copyright) REVEAL(copyright) Insertable Loop Recorder having spaced housing EGM electrodes. More elaborate implantable hemodynamic monitors (IHMs) for recording the EGM from electrodes placed in or about the heart and other physiologic sensor derived signals, e.g., one or more of blood pressure, blood gases, temperature, electrical impedance of the heart and/or chest, and patient activity have also been proposed. The Medtronic(copyright) CHRONICLE(copyright) IHM is an example of such a monitor that is coupled through a lead of the type described in commonly assigned U.S. Pat. No. 5,564,434 having capacitive blood pressure and temperature sensors as well as EGM sense electrodes. Such implantable monitors when implanted in patients suffering from cardiac arrhythmias or heart failure accumulate date and time stamped data that can be of use in determining the condition of the heart over an extended period of time and while the patient is engaged in daily activities. A wide variety of other IMDs have been proposed to monitor many other physiologic conditions as set forth in U.S. Pat. No. 6,221,011.
In addition, while the typical patient receives only one such IMD, there is growing realization that more than one such IMD may be implanted in a single patient as suggested in commonly assigned U.S. Pat. No. 4,987,897 and in U.S. Pat. Nos. 4,886,064 and 4,494,950, for example. For example, IMDs such as an ICD or a pacemaker, a neurological implant, a drug pump, a separate physiologic monitor and various other IMDs may be implanted into a single patient. As suggested in the ""897 patent, it may be preferred to have an operable communication between the various IMDs to provide a coordinated clinical monitoring and therapy to the patient on a real-time basis.
In many cases drug regimens are also prescribed for patients having IMDs, and the health care provider must monitor and manage both the prescribed drug therapies and the IMD functions.
Continuous updating and monitoring of the IMDs is necessary to successfully manage the operations and assess the performance of each IMD in the patient receiving one IMD, much less multiple IMDs and interactions with drug therapies. There is a need to monitor the performance of the IMDs on a regular, if not a continuous, basis to ensure optimal patient care. In the absence of other alternatives, this imposes a great burden on the patient if a hospital or clinic is the only center where the necessary frequent follow up, evaluation and adjustment of the IMDs could be made. Moreover, even if feasible, an increasing number of health care providers and increased numbers of service areas or clinic centers would be required to provide adequate medical care to the burgeoning number of patients implanted with one or more IMD worldwide.
Medical care providers are also burdened by the need to continually remain abreast of the advancement of medical science, particularly medical advances or failures in diagnosis and treatment of the patient population under their care as well as disease trends. A wide variety of national and international professional, governmental, research and educational institutions and agencies exist to provide information and training to medical care providers. For example, the National Institutes of Health and the Centers for Disease Control conduct research and accumulate data into statistical databases that are employed by researchers to analyze disease trends and inform the medical community. This body of xe2x80x9cmedical knowledgexe2x80x9d accumulates at a rapid pace and must be disseminated to the medical community in a timely and effective manner.
As patient population, medical knowledge, and IMD technology expand exponentially, costs also increase such that considerable efforts are brought to bear to make the provision of health care far more efficient and cost effective. A wide variety of initiatives have been undertaken to control costs. Substantial increases in productivity and quality have been associated with the computerization of the work place and the proliferation of information technologies that involve transmission of information between computers leading to a lowering of costs in many industries. Multiple types or combination of network architectures have been put into place, including community access television (CATV) networks, the public switched telephone network (PSTN), the integrated services digital network (ISDN), the Internet, local area networks (LAN), wide area networks (WAN), wireless communications networks, asynchronous transfer mode (ATM) networks, etc, to facilitate such data transmission. Software and hardware developments have also increased the computing and data transmission capabilities of servers, computer workstations, personal computers, and the ever-increasing variety of other peripheral devices capable of accessing a network leading to xe2x80x9cpervasive computingxe2x80x9d.
These developments are being brought to bear in the effort to control the costs of medical and health care, particularly of patients who are not confined to a health care facility, in a wide variety of ways. Over the years, many systems have been advanced for remote monitoring of patients through radio or telephone communication or xe2x80x9ctelemedicinexe2x80x9d links as disclosed, for example, in U.S. Pat. No. 5,544,661. More recently, systems for effecting interactive communication and remote monitoring of ambulatory patients have been proposed employing Internet based information technologies as disclosed in U.S. Pat. No. 5,997,476 and in PCT Publication Nos. WO 99/14882 and WO 99/41682, for example. Various systems have been proposed to provide medical information and assistance to patient subscribers to Internet based services as disclosed in PCT Publication No. WO 00/70529, for example.
Other systems have been proposed for assembling large scale integrated database management systems for patient data that can be accessed by subscribers in the health care field to obtain information pertinent to the treatment of a patient under their care as described in U.S. Pat. No. 6,067,542 and other articles and patents referenced therein. The ""542 patent discloses data mining techniques for performing outcomes research against the consolidated patient records in the database to evaluate the critical pathways. Other data mining techniques applicable to medical research are disclosed in U.S. Pat. Nos. 5,875,285 and 5,908,383.
Advances in computing and information technologies have also been contributed to the design and manufacture of the above-described IMDs and programmers. Virtually all IMDs and external programmers providing the telemetry capability have a microcomputer-based architecture. These advances have enabled the above-described proliferation of types of IMDs and advancement in their capabilities while tending to not increase their costs.
It has been recognized that there is a need to reduce the cost of conducting telemetry sessions that are borne by the medical care provider and imposed on the patient in terms of lost work time. Moreover, it has been recognized that the information technologies and available networks introduce the possibility of chronic and continuous monitoring of IMDs wherever the IMD-bearing patient may happen to be at any given time as set forth, for example, in commonly assigned U.S. Pat. Nos. 5,752,976 and 6,083,248.
Thus, a number of proposals have been advanced to facilitate conducting telemetry sessions with IMDs virtually automatically employing information technologies and available networks of the types listed above. Typically, a central database and communications center is manned by a staff that initiates a remote telemetry session and overseas the collection of the data and analyzes it. For example, it has been proposed in the above-referenced ""011 patent that a wide variety of patient data be automatically collected from an IMD in a patient, transmitted over an available network to a remote center, and maintained in a patient care record in a centralized database at the center. Baseline and updated patient data are maintained in the patient care record by a database server. The patient data is manipulated to make a determination of patient xe2x80x9cwellnessxe2x80x9d.
There remains a need to assist the medical care provider in managing such patients (and the associated data) having a variety of disease syndromes and implanted with one or more IMD of the types described having broad capabilities of providing an ever-increasing amount of IMD developed patient data in light of other patient data derived from other sources, IMD data available from manufacturer""s and government sources, and the large body of general healthcare information. There remain unmet needs to provide for the integration, structuring, and analytical processing of the vast bodies of IMD data, patient data, and general healthcare information in order to develop and deliver new and unique clinical tools to help physicians better manage chronically ill patients, e.g., to improve diagnosis, monitoring, to assess therapy effectiveness and to optimize the monitoring and therapy deliveries by the IMDs.
In view of the above need, the present invention provides a system and method of managing the medical care of a patient having one or more IMD implanted in the patient""s body to deliver a therapy and/or monitor a physiologic condition of the patient and capable of communicating patient data externally to a remote receiver. The receiver is in communication with a centralized medical information network that is capable of developing and delivering new and unique clinical tools to help physicians better manage chronically ill patients.
The centralized medical information network has a centralized database and accepts the IMD-developed patient data, and also receives, or has access to, other patient data derived from other sources. This may include IMD data available from manufacturers and government sources, and the large body of general healthcare information in established public domain databases, governmental repositories, and international health agency databases. Deep computing technologies are then applied to the assembled body of data to develop and provide patient-specific information to the health care provider, the patient, or the patient""s family.
The present invention advantageously provides patient-specific information for IMD-bearing patients that draws upon worldwide expertise and knowledge of IMDs of the type implanted, the patient""s disease etiology, the drugs prescribed to the patient, the knowledge of experts in the field, and the optimal modes of operating the IMD to monitor physiologic conditions or apply therapies as reported by experts and medical device manufacturers.
The present invention in one embodiment operates by providing patient data to a patient file at a centralized information database. The patient data includes IMD-developed patient data received from the IMD. Statistical data from public domain databases such as governmental and international health agency repositories is also obtained. Then deep computing techniques are applied to mine the accessed statistical data to associate pertinent statistical data with the patient data in the patient file to form a patient-specific medical profile. Further, based upon the patient-specific medical profile, the invention formulates patient-specific information, and delivers the formulated patient-specific information to one or more of the patient and the health care providers that is providing care to the patient.
The applying step further comprises applying one or more of algorithmic design and analysis, mathematical modeling and trend analysis, statistical estimation, and data/pattern recognition to the statistical data based upon the patient data to effect the association of relevant statistical data with the patient data to form the patient specific medical profile. This profile allows the most effective therapy regimen to be implemented. Further, predictive models are implemented using a derived patient profile to prospectively anticipate future health problems and recommend a proactive/pre-emptive course of action. Some of the deep computing analytical techniques that could be applied to the assembled database include data mining (extracting useful information from very large sets of data); interpolation and approximation (for estimating the trends of dynamic systems such as patient status improving or worsening); pattern discovery (finding recurring patterns in large, continuous streams of information, particularly continually developed patient data from the IMD (such as an EGM, or pressure waveforms); text mining (machine reading of textual information to discover insights e.g. from patient histories or subjective assessments); neural networks and fuzzy logic (expert systems and relational databases based on predictive algorithms); cluster analysis (determining the meaning of low frequency events that possess similarities); pattern discovery (understanding new meaning from analysis of patterns such as those inherent in EKG""s, cardiac pressure waveforms, etc.); and other statistical methods and predictive algorithms related to low and high frequency data events.
The patient data provided to the patient file can include patient laboratory test data of laboratory tests of the patient, clinical test data of clinical tests of the patient, pharmaceutical prescription data of drugs prescribed for the patient, other care provider data accumulated by the care providers providing medical care to the patient, physical examination records and patient reported symptoms.
The patient data derived from sources other than the IMD developed patient data and provided to the patient file, can include the patient""s genomic data (DNA) and other relevant clinical information developed about the patient, including all patient records, prescribed drug regimens and data derived from interviews with the patient and the patient""s family, and other data collected in the home or elsewhere about the patient""s status, e.g., family histories, weight, glucose results, etc., e.g., by telephone data entry. In the cardiac monitoring context, significant information about drug interaction and heart irregularities could be correlated with specific DNA signatures. Gene expression tools used to study drug-disease interactions can be extended to develop diagnostic algorithms, monitoring indicators and individual therapies based on deeper knowledge resulting from integrating and analyzing gene expression profiles with IMD developed patient data, drug regimens, and other relevant clinical/patient information. Gene expression tools may also be used to proactively design therapy regimens based on genetically-inherited latent health problems.
The formulating step further comprises formulating one or more of an individualized care plan, tailored action plans and reminders, progress reports, tailored rules by patients, physician and disease state, and automatically generated and communicated messages and alerts.
This summary of the invention has been presented here simply to point out some of the ways that the invention overcomes difficulties presented in the prior art and to distinguish the invention from the prior art and is not intended to operate in any manner as a limitation on the interpretation of claims that are presented initially in the patent application and that are ultimately granted.